🏛️ Verified NIH Record • Updated 2026-04-03
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS (NCT06144645)
A Phase 3, Randomized, Double-Blind, Dose-Ranging Evaluation of Transcutaneous Vagus Nerve Stimulation (tVNS) to Reduce Temper Outbursts in People With Prader-Willi Syndrome (PWS)
🔵 Active, Not Recruiting Phase3 ⚙️ Medical Device Protocol Sponsor: Foundation for Prader-Willi Research
🩺 Plain-English Summary (8th-Grade Level)
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
Who can join: Review the eligibility criteria below.
Location: Stanford University — Palo Alto, California
Age range: 10 Years to 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- Stanford University — Palo Alto, California
- Rady Children's Hospital San Diego — San Diego, California
- Children's Hospital Colorado — Aurora, Colorado
- Emory University — Atlanta, Georgia
- Rare Disease Research — Atlanta, Georgia
- University of Iowa — Iowa City, Iowa
- Johns Hopkins Hospital — Baltimore, Maryland
- University of Minnesota — Minneapolis, Minnesota
- Children's Mercy Kansas City — Kansas City, Missouri
- Maimonides Medical Center — Brooklyn, New York
- NYU Langone Health — Garden City, New York
- Montefiore Medical Center and Albert Einstein College of Medicine — The Bronx, New York
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Vanderbilt University Medical Center — Nashville, Tennessee
- Christus Children'S — San Antonio, Texas
- University of Utah — Salt Lake City, Utah
- University of Virginia — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prader-Willi Syndrome
- A Study of Setmelanotide in Patients With Prader-Willi Syndrome — Gainesville, Florida
- Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome — Orange, California
- A Study of Pitolisant in Patients With Prader-Willi Syndrome — Los Angeles, California
- Tirzepatide in PWS, HO and GNSO — Saint Paul, Minnesota
- Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation — Kansas City, Missouri
Explore by condition: All Prader-Willi Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.